Huzzah! 23andMe FINALLY Clears FDA — On Some Disease Tests…

We have been following this company — for almost four years now. [Some may recall that we were an early adopting customer, too!]

So it is “well, with my soul” — so good to see them get this much needed FDA nod. More selfishly, now my complete original packet of DNA based diagnostic information will be restored, on the company’s servers — for my perusal and download.

I was able to see these test results initially in 2013, before FDA ruled they needed to be vetted (my later backgrounder is here). Then they were disabled, in the toolkit, until this late week — now they are visible, once again. Very cool! Here’s the NBC story — it happened while I was off-grid, on Thursday:

. . . .”These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional,” the FDA said in a statement. . . .

“Consumers can now have direct access to certain genetic risk information,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, which approves these kinds of tests.

“But it is important that people understand that genetic risk is just one piece of the bigger puzzle. It does not mean they will or won’t ultimately develop a disease.” “These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional,” the FDA said in a statement.

“Consumers can now have direct access to certain genetic risk information,” said Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, which approves these kinds of tests.

“But it is important that people understand that genetic risk is just one piece of the bigger puzzle. It does not mean they will or won’t ultimately develop a disease. . . .”

Now you know — power — in the hands of the health care consumer; properly managed, and understood — it empowers patients to be. . . well. As am I, green across all ten tests! . . . Back, after being out earlier, for a perfect afternoon of mountain biking — to and from a heavy weights session — under clear, azure 70 degree skies! Smile. . . .

नमस्ते

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One Response

  1. I do… see thee, near dinner-time — and did so enjoy the feel… of that… kitchen… smile…

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